Kintsugi Voice Device Pivotal Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age22+
SponsorKintsugi Mindful Wellness, Inc.
About this trial
A prospective, single arm, non-randomized, pivotal clinical validation study to evaluate the ability of the Kintsugi Voice Device (the Device) to aid clinical assessment for depression by comparing its output with a diagnosis made by a clinician using the Structured Clinical Interview for DSM-5 (SCID-5-RV) for up to 1000 English speaking adult patients ages 22 and older living in the United States. Recruitment will occur for 1 year and participation will be for up to 2 weeks
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
This study will enroll up to 1000 English speaking subjects \>22 years old. Only subjects who meet all eligibility criteria and sign the informed consent will be enrolled. Participants who do not meet the criteria required for participation will not be presented with the opportunity to participate. Screen failures will not be considered a part of this research study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Kintsugi Voice Device
DeviceThe Kintsugi Voice Device is intended to be used to screen for the presence of voice signals consistent with a current moderate to severe depressive episode in patients aged 22 and older. The device is intended to be used by care providers licensed to screen for depression and in settings where the screening for depression occurs. The device is neither to be used in lieu of a complete patient evaluation nor to supplant any of the clinician's standard assessments for the screening or diagnosis of depression. The Kintsugi Voice Device is comprised of a software API and machine learning model that utilizes recorded voice samples as inputs and outputs the detection of signals consistent with current moderate to severe depressive episode as outputs.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
1. Sensitivity and Specificity of Kintsugi Voice Device Relative to the SCID-5
Achieve a composite lower bound of sensitivity greater than or equal to 70% and specificity greater than or equal to 70% for the KV Device relative to the high diagnostic confidence clinical reference standard as defined in Section 7.4.1 for which the device provides a result
Time frame
Day 1Secondary outcomes
1
Adjudicated Samples Sensitivity and Specificity
Evaluate sensitivity and specificity for all adjudicated samples for which the device provides a result
Time frame
Day 12
PPV and NPV Evaluation
Evaluate the Positive Predictive Value (PPV) and Negative Predictive Value (NPV)
Time frame
Day 13
Subgroup Analysis (Sensitivity and Specificity)
Perform subgroup analyses including but not limited to age, race, and ethnicity
Time frame
Day 14
Indeterminate Result Analysis
Measurement of the proportion of all participants for whom the device provides no result
Time frame
Day 1Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Kintsugi Mindful Wellness, Inc.
Lead sponsor
Kolby Walker, DO
Collaborator
Sonar Strategies
Collaborator
Brittany Kimble
Collaborator
Source ClinicalTrials.gov